Nipple areola complex stencil

ABSTRACT

Embodiments of the invention include a breast nipple areola complex tattoo stencil comprising first, second and third stencil sections. The first stencil section defines an areola area. The second stencil section defines a nipple area and tubercle areas. One or more registration elements on the first and/or second stencil sections enable registration of the second stencil section to the first stencil section. The third stencil section defines one or both of a nipple shading area and a nipple highlight area. One or more registration elements on the third and/or second stencil sections enable registration of the third stencil section to the second stencil section.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a national phase application of PCT Application No.PCT/US2017/043849, internationally filed on Jul. 26, 2017, entitled,NIPPLE AREOLA COMPLEX STENCIL, which claims the benefit of ProvisionalApplication No. 62/366,843, filed Jul. 26, 2016, entitled, NIPPLE AREOLACOMPLEX STENCIL, both of which are incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The invention relates generally to devices and methods useful inconnection with anatomic cosmetic and reconstruction surgicalprocedures. Embodiments of the invention include stencils and methodsfor tattooing anatomic structures, such as nipple areola complexstructures in connection with breast reconstruction surgical procedures.

BACKGROUND OF THE INVENTION

The nipple areolar complex (NAC) is comprised of the nipple and theareola. The areola contains Montgomery's Tubercles which are sebaceousglands that appear as pale mounds. The areolar skin, which has a darkerpigmentation than the surrounding skin, is anchored to the underlyingbreast with circular muscle fibers. These muscle fibers create acontrast of color variation on the overlying pigmented skin.

Mastectomy as a treatment for breast cancer commonly involves removal ofthe NAC. Following implant or autologous breast reconstruction, the NACcan be reconstructed. Tattooing can be performed to create theappearance of the areola and nipple. Shading and coloring can be used tocreate the appearance of a three dimensional structure. An actual threedimensional structure mimicking a nipple can be created by local flapsand fat grafting a mound, and the three dimensional structure can betattooed. Color variations of the areola are sometimes recreated bytattooing alternating colors in concentric circles. These tattooingprocedures are often done free-hand. Templates having circular openings(e.g., that are cut from adhesive-backed dressings) are sometimes usedin connection with the nipple tattooing procedures (e.g., to define theareola).

There remains a continuing need for improved methods and devices forcosmetic and reconstruction surgery. Devices and methods that canenhance the appearance and efficacy of anatomic structures tattooed on apatient are desired. Such devices and methods for breast reconstructionprocedures would be particularly useful.

SUMMARY

Embodiments of the invention include a method for tattooing a nippleareolar complex on a breast. The method comprises placing a firststencil member defining an areola area on a patient, and tattooing anareola area on the patient using the areola area of the first stencilmember as a guide. A second stencil member defining a nipple area isplaced on the patient and registered to the first stencil member. Anipple area is tattooed on the patient using the second stencil memberas a guide. In embodiments, placing the second stencil member on thepatient further includes placing a second stencil member furtherdefining tubercle areas, and the method further includes tattooingtubercle areas on the patient using the second stencil member as aguide. Embodiments further comprise placing a third stencil memberdefining one or both of a nipple shading area and a nipple highlightarea on the patient, registering the third stencil member to the secondstencil member, and tattooing one or both of the nipple shading area andthe nipple highlight area on the patient using the third stencil memberas a guide.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric front-side view of a nipple areola complex (NAC)tattoo stencil in accordance with embodiments of the invention.

FIG. 2 is an exploded view of the stencil shown in FIG. 2.

FIGS. 3A and 3B are front-side and back-side (i.e., breast-facing)views, respectively, of the stencil shown in FIG. 1, with thehighlight/shading member removed.

FIGS. 4A and 4B are front-side and back-side views, respectively, of thestencil shown in FIG. 1, with the highlight/shading member at a firstposition.

FIGS. 5A and 5B are front-side and back-side views, respectively, of thestencil shown in FIG. 1, with the highlight/shading member at a secondposition.

FIGS. 6A-6D illustrate a sequence of NAC structures that can be tattooedusing the stencil shown in FIG. 1, with FIG. 6A illustrating thecompleted NAC structure.

DESCRIPTION OF THE INVENTION

A nipple areola complex (NAC) tattoo stencil 10 in accordance withembodiments of the invention is illustrated in FIGS. 1, 2, 3A, 3B, 4A,4B, 5A and 5B. As shown, stencil 10 includes a first or areola section12 and a second or nipple section 14. The areola section 12 can be usedas a stencil or template on a reconstructed breast to tattoo an areola.The nipple section 14 is used as a stencil or template to tattoo anipple that is positionally registered to the tattooed areola. Inembodiments, the nipple section 14 can also be configured for use as astencil or template to tattoo other positionally registered structureson the areola, such as Montgomery's Tubercles and/or effects such asshading and highlights that provide an enhanced three-dimensionalappearance to the nipple.

Areola section 12 is ring-shaped in the illustrated embodiment, and hasan annular inner edge surface 16 that defines an areola opening 18.Inner edge surface 16 also provides a registration mating structure inconnection with the nipple section 14. Embodiments of the first orfront-side surface of the areola section 12 have a guide slot or recess20 that can be used during the tattooing process as described below.

The illustrated embodiment of nipple section 14 includes an adapter 24,nipple/tubercle member 26 and shading member 28. Nipple/tubercle member26 is disk-shaped in the illustrated embodiment, and has an annularouter edge surface 29, an interior edge surface 30 that defines a nippleopening 32, and a plurality of interior edge surfaces 34 that definetubercle openings 36. As shown, the tubercle openings 36 are spacedaround the nipple opening 32. Adapter 24 is a ring-shaped device in theembodiment shown, and has a wall 38 with an outer surface (not visiblein the drawings) that mates with the annular inner edge surface 16 ofthe areola section 12. An inner edge surface 40 of the adapter wall 38mates with the outer edge surface 29 of the nipple/tubercle member 26.The mating structures and surfaces of the areola section 12, adapter 24and nipple/tubercle member 26 function as registration structures toregister the nipple/tubercle member with respect to the areola section12 (i.e. to cause the nipple opening 32 and tubercle openings 36 to bepositioned at desired locations with respect to the areola opening 18).

Shading member 28 (which is optional in embodiments) has an edge surface50 that defines a nipple/highlight opening 52, and an edge surface 54that defines a shading opening 56. In the embodiment shown, the edgesurface 50 defines a generally semicircular area of the nipple/highlightopening area 52, and the shading opening 56 defines a crescent-shapedshading opening 56. The shading member 28 is configured to be movedbetween and located at first and second positions on the nipple/tuberclemember 26. In the illustrated embodiment, the shading member 28 moveswithin a recess 68 in the nipple/tubercle member 26. The movement andpositioning of the shading member 28 are facilitated by side walls 58and end wall portions 60 and 62. Side walls 58 have outer surfaces 64that mate with inner walls 66 of the recess 68 in the nipple/tuberclemember 26, and enable the shading member 28 to slide between the firstand second positions.

FIGS. 4A and 4B show the shading member 28 in a first or open position,with the end wall portion 62 engaged with a lip 70 on the adapter 24. Asshown in FIGS. 4A and 4B, when the shading member 28 is in the firstposition, the edge surface 50 cooperates with the edge surface 30 of thenipple/tubercle member 26 to define a generally circular nipple areawithin the nipple opening area 32 of the nipple/tubercle member 26 andthe nipple/highlight opening area 52 of the shading member. FIGS. 5A and5B show the shading member 28 in a second or closed position, with theend wall portion 60 engaged with an edge wall surface 72 of the recess60 in the nipple/tubercle member 26. As shown in FIGS. 5A and 5B, whenthe shading member 28 is in the second position, the edge surface 50cooperates with the edge surface 30 of the nipple/tubercle member 26 todefine a generally crescent shaped nipple highlight area within andadjacent a top edge of the nipple opening area 32 of the nipple/tuberclemember 26 and the nipple/highlight opening area 52 of the shadingmember. When in the second position, the shading member 28 also locatesthe shading opening 56 within and adjacent a bottom edge of the nippleopening area 32 of the nipple/tubercle member 26.

FIGS. 6A-6D illustrate a sequence of steps by which a NAC tattoo 80 canbe tattooed on a reconstructed breast using embodiments of the stencil10. In embodiments, and as shown in FIG. 6A, an areola tattoo 82 can(but need not) be applied to the breast first. The areola tattoo 82 canbe applied using the areola section 12 (e.g., edge surface 16 definingthe areola opening 18) as a guide. In embodiments, a first or backgroundcolor tone can be used for the areola tattoo 82. For example, with thenipple/tubercle section 14 removed from the areola section 12, theareola section can be placed on the breast and the areola tattoo 82 canbe applied in the areola opening 18. The areola section 12 can bereleasably secured to the breast during the application of the areolatattoo 82, for example by adhesive on the bottom, breast-facing side ofthe areola section. In other embodiments, a layer of adhesive material(not shown) such as transparent 3M™ Tegaderm™ dressing can be appliedover the top and beyond the peripheral edges of the areola section 12 tosecure the areola section to the breast. The section of the adhesivematerial over the areola opening 18 can be cut away by a scalpel usingrecess 20 as a guide and barrier, and the cut away material removed toprovide access to the areola opening 18. In embodiments, the areolasection 12 can be packaged in a sterile package (not shown) having thelayer of adhesive material and a protective release liner over theadhesive. In these embodiments, after removing the areola section 12from the package, the release liner can be removed from the layer ofadhesive material before applying and using the areola section in themanner described above.

In embodiments, after the areola tattoo 82 is applied, the nipplesection 14 can be mounted to the areola section 12, and the shadingmember 28 moved to the first or open position. A nipple tattoo 84 canthen be applied, using the nipple/tubercle member 26 and shading member28 (e.g., edge surfaces 30 and 50 defining the nipple area within thenipple opening area 32) as a guide. In embodiments, the nipple tattoo 84is applied using a second color tone that is lighter than the firstcolor tone of the areola tattoo 82.

Tubercle tattoos 85 are applied in embodiments using the nipple/tuberclemember 26 (e.g., edge surfaces 34 defining tubercle openings 36) asguides. In embodiments, the tubercle tattoos 85 are applied using athird color tone that is lighter than the second color tone of thenipple tattoo 84.

In embodiments where it is desired to apply a nipple highlight tattoo 86and/or shading tattoo 88, the shading member 28 can be moved to thesecond or closed position. The nipple highlight tattoo 86 can be appliedusing the nipple/tubercle member 26 and shading member 28 (e.g., edgesurfaces 30 and 50 defining the nipple highlight area within the nippleopening area 32) as a guide. In embodiments, the nipple highlight tattoo86 is applied using the third color tone. The nipple shading area tattoo88 can be applied using the shading member 28 (e.g., edge surface 54defining the shading opening 56) as a guide. In embodiments, the nippleshading tattoo 88 is applied using a fourth color tone that is darkerthan the first color tone.

Other embodiments of the invention use different color tone palates thanthose described above. In embodiments, the color tones can be determinedelectronically/optically by imaging colors of the associated NACstructures of the patient's pre-operative breast. Still otherembodiments include more or fewer tattoo areas. For example, the stencil10 can include additional stencil areas to enhance the visual appearanceof the tattoo. In embodiments, electronic imaging can be used todetermine the structures of the patient's pre-operative breast, and usedto generate custom stencils 10 (e.g., by 3-D printing) having structuresthat provide tattoos corresponding to the patient's original NACstructures (e.g., sizes, shapes and locations of the areola, nipple andtubercles). The stencil 10 can be manufactured from plastic or othermaterials. Other embodiments of the invention tattoo the different NACstructures in different orders.

Although the invention has been described with reference to preferredembodiments, those skilled in the art will recognize that changes can bemade in form and detail without departing from the spirit and scope ofthe invention. For example, stencils in accordance with embodiments ofthe invention can be used for other tattooing applications, such as scarcamouflage, hair transplant camouflage, simulation of genitalia,simulation of anus, and other anatomical sites. Alternatively and/or inaddition to the mating structures, visual alignment indicia such aslines or other marks can be located on the various sections and membersof the stencil to provide the registration functionality.

The invention claimed is:
 1. A breast nipple areola complex tattoostencil, comprising: a first stencil section defining an areola area; asecond stencil section defining a nipple area; one or more registrationelements on the first and/or second stencil sections, to enableregistration of the second stencil section to the first stencil section;a third stencil section defining one or both of a nipple shading areaand a nipple highlight area; one or more registration elements on thethird and/or second stencil sections, to enable registration of thethird stencil section to the second stencil section; wherein the one ormore registration elements on the third and/or second stencil sectionsincludes mating structures on the second and third stencil sections,enabling the third stencil section to engage and mate with the secondstencil section; wherein the mating structures on the second and thirdstencil sections enable the third stencil section to slide on the secondstencil section between a first position and a second position; whereinwhen the third stencil section is at the first position the thirdstencil section provides access to the nipple area of the second stencilsection, and wherein when the third stencil section is at the secondposition the third stencil section registers the one or both of thenipple shading area and the nipple highlight area with respect to thenipple area of the second stencil section.
 2. The stencil of claim 1wherein the second stencil section further defines tubercle areas. 3.The stencil of claim 1 wherein the one or more registration elementsinclude mating structures on the first and second stencil sectionsenabling the second stencil section to engage and mate with the firststencil section.
 4. The stencil of claim 3 wherein the mating structuresinclude: a first diametrical surface portion on the first stencilsection; and a second diametrical surface portion on the second stencilsection, wherein the second diametrical surface portion of the secondstencil section engages the first diametrical surface portion of thefirst stencil section.
 5. The stencil of claim 1 wherein the thirdstencil section defines both the nipple shading area and the nipplehighlight area.
 6. The stencil of claim 1 and further including adhesiveon the first stencil section to releasably secure the first stencilsection to a breast.
 7. The stencil of claim 6 wherein the adhesive ison a base layer of material extending peripherally from the firststencil section.
 8. The stencil of claim 7 wherein the base layer ofmaterial extends over the areola area, and the portion of the base layerof material extending over the areola area can be removed prior to useof the first stencil section.
 9. The stencil of claim 8 wherein thefirst stencil section further includes a guide, to facilitate removal ofthe base layer of material extending over the areola area.
 10. Thestencil of claim 6 and further including a protective release layer overthe adhesive.
 11. A method for tattooing a nipple areolar complex on abreast, including: placing a first stencil member defining an areolaarea on a patient; tattooing an areola area on the patient using theareola area of the first stencil member as a guide; placing a secondstencil member defining a nipple area on the patient; registering thesecond stencil member to the first stencil member; and tattooing anipple area on the patient using the second stencil member as a guide.12. The method of claim 11 wherein: placing the second stencil member onthe patient further includes placing a second stencil member furtherdefining tubercle areas; and the method further includes tattooingtubercle areas on the patient using the second stencil member as aguide.
 13. The method of claim 11 wherein registering the second stencilmember to the first stencil member includes engaging the second stencilmember to the first stencil member by mating structures.
 14. The methodof claim 11 and further including: placing a third stencil memberdefining one or both of a nipple shading area and a nipple highlightarea on the patient; registering the third stencil member to the secondstencil member; and tattooing one or both of the nipple shading area andthe nipple highlight area on the patient using the third stencil memberas a guide.
 15. The method of claim 14 wherein the steps of placing thesecond and third stencil members on the patient include placing anassembly including both the second and third stencil members on thepatient.
 16. The method of claim 15 wherein: placing the assemblyincluding the second and third stencil members on the patient includesplacing an assembly having the third member that is movable betweenfirst and second positions on the second member; tattooing the nipplearea includes tattooing the nipple area when the third member is at thefirst position on the second member; the method further includes movingthe third member to the second position; and tattooing one or both ofthe nipple shading area and the nipple highlight area when the thirdstencil member is at the second position.
 17. The method of claim 11 andfurther including adhesively attaching the first stencil member to thepatient.
 18. The method of claim 17 wherein: the first stencil memberincludes a base layer of material including a portion extending acrossthe areola area and a portion extending peripherally from the firststencil member, and wherein at least the portion of the base layerextending peripherally from the first stencil member includes adhesiveand a release layer covering the adhesive; and adhesively attaching thefirst stencil member to the patient includes: removing the base layer ofmaterial from the areola area; removing a release layer from theadhesive on a base layer of material extending peripherally of the firststencil member; and attaching the first stencil member to the patientusing the adhesive on the portion of the base layer extendingperipherally of the first stencil member.
 19. The method of claim 18wherein removing the base layer of material includes cutting the baselayer using a cutting guide in the first stencil member.
 20. The methodof claim 11 and further including: pre-operatively imaging the patient'snipple areolar complex; deriving data representative of one or both ofthe color and shapes of any one or more of the areola, tubercles andnipples from the image; and manufacturing one or more of the stencilmembers using the derived data; and selecting one or more colors for thetattooing using the derived data.